Senior Manager Regulatory / Medical Writer

Your new company

I'm currently supporting an exciting opportunity with an innovative biotechnology organisation developing cutting-edge therapies.
We're looking for an experienced Senior Manager, Medical/Regulatory Writer to lead and oversee regulatory and medical writing activities across clinical development programmes, supporting submissions from First-in-Human studies through to product registration.

Location: Remote (UK-based), ability to attend the Oxford office 1-2 days per week would be advantageous.Contract: 12 Months initially

Your new role

Key Responsibilities

• Lead regulatory and medical writing activities across assigned development programmes
• Author and review key regulatory documents including:
• Clinical Study Protocols
• Clinical Study Reports (CSRs)
• Investigator Brochures (IBs)
• DSURs
• Clinical Overviews and Clinical Summaries
• Health Authority Briefing Documents
• Responses to Regulatory Agency Questions
• IND/CTA and CTD/BLA/MAA submission documentation
• Coordinate and manage external contract writers
• Ensure consistency of regulatory messaging across programmes
• Partner with Clinical, Regulatory, Pharmacovigilance, Translational Medicine, Medical Affairs, and Preclinical teams
• Contribute to medical writing best practices, process improvements, and submission strategies

What you'll need to succeed

• Extensive pharmaceutical or biotechnology industry experience within Medical and Regulatory Writing with TA experience in oncology, biologics, immunology or other innovative therapeutic areas would be highly advantageous.

Proven experience authoring:

• Protocols
• CSRs
• Investigator Brochures
• Health Authority briefing documents
• Regulatory submission documentation

• Strong understanding of global (US and EU) regulatory requirements and submission strategy
• Experience supporting global development programmes
• Excellent stakeholder management and leadership skills
• Ideally experience within biologics and innovative development programmes

Desirable Experience

• Master/Sub Protocols
• Umbrella or Basket Studies
• Rapid Health Authority responses (RFIs)
• eDMS and/ or RIMS systems
• Electronic document review platforms

What you need to do now

This is an excellent opportunity for a senior medical writer who enjoys working in a highly innovative, agile environment and wants to play a key role in shaping regulatory strategy for novel therapies.

Before you apply for this position, it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

If you are an experienced Medical Writing professional available for a 12-month contract, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on